Vancomycin hydrochloride is available in single-dose vials containing drug equivalent to 250 mg, 500 mg, 750 mg, 1 g, 1.25 g, and 1.5 g of vancomycin base, and pharmacy bulk packages containing drug equivalent to 5, 10, and 100 g of vancomycin base.3464; 3465; 3466; 3467; 3468; 3469 To reconstitute single-use vials, 5 mL of sterile water for injection should be added for each 250 mg of vancomycin lyophilized powder contained in the vial (e.g., add 15 mL of sterile water to reconstitute a 750-mg vial of vancomycin) to yield a solution with a vancomycin concentration of 50 mg/mL.3464; 3465; 3466 Pharmacy bulk packages containing 5 g of vancomycin should be reconstituted with 100 mL of sterile water for injection to yield a solution with a vancomycin concentration of 50 mg/mL.3467; 3468 Pharmacy bulk packages containing 10 or 100 g of vancomycin should be reconstituted with 95 or 950 mL, respectively, of sterile water for injection to yield a solution with a vancomycin concentration of 100 mg/mL.3467; 3469 The appropriate dose of the reconstituted solution prepared from single-dose vials must be further diluted in a compatible diluent to achieve a final vancomycin concentration of 5 mg/mL (e.g., 500 mg in at least 100 mL, 750 mg in at least 150 mL, 1 g in at least 200 mL).3464; 3465; 3466 The appropriate dose of the reconstituted solution prepared from pharmacy bulk packages must be further diluted in at least 100 mL of a compatible diluent;3467; 3468; 3469 some manufacturers state that doses of 1 g must be diluted in at least 200 mL of a compatible diluent.3467; 3468 Manufacturers state that vancomycin concentrations of no more than 5 mg/mL are recommended in adults.3464; 3465; 3466; 3467; 3468; 3471; 3472 More concentrated vancomycin solutions (i.e., up to 10 mg/mL) may be considered for use in selected patients (e.g., fluid-restricted patients); however, use of such solutions increases the risk of infusion-related adverse effects.3464; 3465; 3466
Vancomycin hydrochloride is available in ADD-Vantage vials containing drug equivalent to 500 mg, 750 mg, and 1 g of vancomycin base.3472 ADD-Vantage vials containing 500 mg of vancomycin should be prepared with at least 100 mL of dextrose 5% or sodium chloride 0.9% in ADD-Vantage diluent bags; ADD-Vantage vials containing 750 mg or 1 g of vancomycin should be prepared only with 250 mL of dextrose 5% or sodium chloride 0.9% in ADD-Vantage diluent bags.3472 The manufacturer states that the use of ADD-Vantage vials is indicated only when doses reflecting the full strength of the available products are determined to be appropriate; if vancomycin doses of 500 mg, 750 mg, or 1 g are not appropriate (e.g., in neonates, infants, and pediatric patients requiring doses less than 500 mg), conventional vials of vancomycin hydrochloride should be used.3472
Vancomycin hydrochloride also is available in several ready-to-use formulations.3470; 3471 Vancomycin hydrochloride is available as a frozen iso-osmotic premixed injection in single-dose Galaxy containers containing the equivalent of 500 mg, 750 mg, and 1 g of vancomycin base in 100, 150, and 200 mL, respectively, of dextrose 5% or sodium chloride 0.9%.3470 Each 100 mL of the premixed solution also contains either 5 g of dextrose hydrous or 0.9 g of sodium chloride, and the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.3470 Vancomycin hydrochloride is available as a premixed injection in single-dose bags containing the equivalent of 500 mg, 1 g, 1.5 g, and 2 g of vancomycin base in 100, 200, 300, and 400 mL, respectively.3471 Each 100 mL of the premixed solution also contains polyethylene glycol (PEG) 400 1.8 mL, N-acetyl-D-alanine (NADA) 1.36 g, and L-lysine hydrochloride (monochloride) 1.26 g in water for injection; hydrochloric acid and sodium hydroxide are used for pH adjustment.3471 The PEG- and NADA-containing formulation should not be used in certain patients (e.g., pregnant women, patients younger than 1 month of age, pediatric patients 1 month of age or older requiring less than the entire dose of a single-dose flexible bag).3471
pH
A 50- or 100-mg/mL reconstituted solution of vancomycin prepared with sterile water for injection has a pH ranging from 2.5 to 4.5.3464; 3466; 3467; 3468; 3469
Premixed infusion solutions of vancomycin (Baxter) 5 mg/mL in dextrose 5% or sodium chloride 0.9% have a pH ranging from 3 to 5.3470
Premixed infusion solutions of vancomycin (Xellia) 5 mg/mL have a pH ranging from 4.5 to 5.5.3471
Osmolality
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 50 mg/mL in sterile water for injection has an osmolality of 57 mOsm/kg.50
The osmolality of vancomycin hydrochloride (Lederle) prepared at a vancomycin concentration of 5 mg/mL was determined to be 249 mOsm/kg in dextrose 5% and 291 mOsm/kg in sodium chloride 0.9%.1375
The osmolality of vancomycin hydrochloride (Sandoz) prepared at a vancomycin concentration of 62.5 mg/mL was determined to be 363 to 383 mOsm/kg in dextrose 5% and 337 to 351 mOsm/kg in sodium chloride 0.9%.3603 The osmolality of vancomycin hydrochloride (Sandoz) prepared at a vancomycin concentration of 83.3 mg/mL was determined to be 379 to 409 mOsm/kg in dextrose 5% and 362 to 378 mOsm/kg in sodium chloride 0.9%.3603
The osmolalities of vancomycin hydrochloride (Sandoz) in sodium chloride 0.9% were measured for the following diluents and concentrations:4006
| Diluent Used for Reconstitution | Vancomycin Concentration in Sodium Chloride 0.9% (mg/mL) | Osmolality (mOsm/kg) |
|---|---|---|
| Sterile water for injection | 25 | 174 |
| 40 | 92 | |
| 60 | 73 | |
| 80 | 72 | |
| Sodium chloride 0.9% | 25 | 319 |
| 40 | 326 | |
| 60 | 354 | |
| 80 | 352 |
Osmolarity
The osmolarity of premixed infusion solutions of vancomycin (Xellia) 5 mg/mL ranges from 350 to 475 mOsmol/L.3471
Vancomycin hydrochloride is administered by intravenous infusion.3464; 3465; 3466; 3467; 3468; 3469; 3470; 3471; 3472 The reconstituted solution must be diluted in a compatible infusion solution prior to administration.3464; 3465; 3466; 3467; 3468; 3469 The drug is extremely irritating to tissue and may cause necrosis; therefore, it should not be given by intramuscular injection and extravasation should be avoided during intravenous administration.3464; 3465; 3466; 3467; 3468; 3469; 3470; 3471; 3472 The frequency and severity of thrombophlebitis can be minimized by administering the drug slowly, using dilute solutions of 2.5 to 5 mg/mL, and rotating venous access sites.3464; 3465; 3466; 3467; 3468; 3469; 3470; 3471; 3472
Manufacturers recommend intermittent intravenous infusion as the preferred method of administration.3464; 3466; 3467; 3468; 3469; 3470; 3472 Some manufacturers recommend that the drug be administered over a period of at least 60 minutes in adults.3465; 3471 Other manufacturers state that administration rates of no more than 10 mg/min are recommended in adults or that the drug should be administered at a rate no faster than 10 mg/min or over a period of at least 60 minutes, whichever is longer.3464; 3466; 3467; 3468; 3469; 3470; 3472 In pediatric patients, the drug should be administered over a period of at least 60 minutes;3464; 3465; 3466; 3467; 3468; 3469; 3470; 3471; 3472 in neonates, the drug should be administered over a period of 60 minutes.3464; 3465; 3466; 3467; 3468; 3469; 3470; 3472
Vancomycin hydrochloride (Baxter) frozen iso-osmotic premixed injection in single-dose Galaxy containers should be thawed (see Stability: Freezing Solutions), and the solution should be administered by intravenous infusion.3470
Vancomycin hydrochloride is a lyophilized powder that varies in color from white or off white to light tan, tan, buff, or brownish.3464; 3465; 3467; 3468; 3469 Intact vials and pharmacy bulk packages should be stored at controlled room temperature.3464; 3465; 3466; 3467; 3468; 3469 Manufacturers indicate that after reconstitution, single-dose vials of vancomycin hydrochloride may be stored in a refrigerator for 14 days with no significant loss of potency;3464; 3465; 3466 other information has indicated that the drug also is stable in solution for 14 days at room temperature.141
Intact ADD-Vantage vials of vancomycin hydrochloride should be stored at controlled room temperature.3472 Solutions prepared using the ADD-Vantage vials may be stored in a refrigerator 14 days for with no significant loss of potency.3472
pH Effects
In the pH range of 2 to 10, vancomycin hydrochloride degradation occurs principally via deamidation.1927 Vancomycin hydrochloride has been reported to be most stable at pH 3 to 5141 and at pH 5.5,1927 with relatively pH-independent decomposition in the range of 3 to 8.1927 The stability of a 1-mg/mL concentration was evaluated in buffer solutions having pH values of 1.4, 5.6, and 7.1 at 24°C. Little or no loss occurred in 24 hours in any solution. However, the pH 1.4 buffer had a 19% loss in 5 days, the pH 5.6 buffer had a 10% loss in 17 days, and the pH 7.1 buffer had an 11% loss in 5 days.1134
In an accelerated study at 66°C, the half-life of vancomycin B (the largest component of the commercial product) was 400 minutes in a phosphate buffer with a pH of 2.2 and 650 minutes in a phosphate buffer with a pH of 7.1354
Vancomycin hydrochloride has a low pH and may cause chemical or physical instability when mixed with other drugs, especially drugs with an alkaline pH.873; 3464; 3465; 3466; 3467; 3468; 3469; 3471; 3472
The concentration dependency of compatibility or incompatibility of vancomycin hydrochloride mixed with or administered simultaneously with a number of penicillins and cephalosporins has been demonstrated.2189 Vancomycin hydrochloride is variably compatible with drugs having neutral to mildly alkaline pH, including cephalosporins and penicillins. The compatibility may depend on a number of factors including concentration of each drug, dilution vehicle, actual pH of solutions, and completeness of mixing during administration. Combinations that are compatible when well mixed may result in precipitation if only partially mixed, presumably due to regionally different concentrations and pH values. If attempting to administer vancomycin hydrochloride with another drug product, care should be taken to ensure that the specific combination and concentrations are compatible under the exact administration conditions to be used. An inline filter should be used as a final safety measure.2189
Freezing Solutions
The commercially available, premixed frozen injection of vancomycin hydrochloride in single-dose Galaxy containers should be stored in a freezer capable of maintaining the temperature at or below -20°C.3470 Frozen product containers should be handled with care since they may be fragile in the frozen state.3470 Freezing of the solution may cause components of the solution to precipitate, but this precipitate will dissolve at room temperature, apparently without affecting potency.3470 Solutions should be thawed at room temperature (25°C) or under refrigeration (5°C).3470 Solutions should not be subject to force thawing (e.g., by immersion in water baths or microwaving).3470 Thawed solutions should not be refrozen.3470 After the thawed solution has reached room temperature, the solution should be agitated.3470 The manufacturer indicates that thawed solutions remain chemically stable for 72 hours at room temperature (25°C) or 30 days refrigerated (5°C).3470
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 5 mg/mL in dextrose 5% or sodium chloride 0.9% exhibited no loss after 63 days of storage when frozen at -10°C. However, neither did a loss occur in the same time period when the solution was stored at 5°C.1134
In one study, vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 5 mg/mL in dextrose 5% was stored frozen at -20°C for 105 days. After thawing in a microwave, the samples were stored for 56 more days under refrigeration. The samples remained clear and had no color change. In addition, no loss of vancomycin occurred throughout the entire test period.2682
Vancomycin hydrochloride (Pfizer) prepared at a vancomycin concentration of 1 g in 10 mL in sterile water for injection in syringes (Becton Dickinson) was stored frozen at -22 to -18°C for 60 days in the dark followed by thawing at room temperature (20 to 24°C) and additional storage at room temperature for 24 hours with approximately 10 hours exposure to light.3895; 3896 2.8% loss of drug was noted in samples assayed immediately after thawing and in samples that were stored for an additional 24 hours at room temperature.3895
Syringes
The stability of vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 5 mg/mL in dextrose concentrations ranging from 5 to 30% and packaged in plastic syringes was studied. The syringes were stored at 4°C for 24 hours followed by 2 hours at room temperature. Little change in the concentration occurred.1301
The stability of vancomycin hydrochloride (Lilly) reconstituted to a vancomycin concentration of 10 mg/mL with sterile water for injection, dextrose 5%, and sodium chloride 0.9% repackaged into plastic syringes was studied. Five mL of the solutions were filled into 3-piece Plastipak (Becton Dickinson) and 2-piece Injekt (Braun) syringes that were then sealed with Luer-Lok hubs (Vigon) and stored at 4 and 25°C for 84 days. Under refrigeration, vancomycin hydrochloride prepared with all 3 solutions and packaged in both kinds of syringes was physically and chemically stable for the 84-day period; losses were 4% or less.1893 However, stored at 25°C in the Plastipak syringes, 10% loss occurred in about 47 days in water, 55 days in dextrose 5%, and 62 days in sodium chloride 0.9%. In the Injekt syringes, stability was less; 10% loss occurred in 29 days in water, 33 days in dextrose 5%, and 34 days in sodium chloride 0.9%. In addition, a degradation product appeared as a white flocculent precipitate in all room temperature samples after about 8 weeks of storage.1893
Vancomycin hydrochloride prepared at a vancomycin concentration of 5 mg/mL in dextrose 5% and in sodium chloride 0.9% packaged in polypropylene syringes (Becton Dickinson) exhibited less than 10% loss in 14 days at room temperature and in 6 months under refrigeration. Refrigerated solutions warmed to room temperature were stable for 48 hours.2730
Vancomycin hydrochloride (Mylan) prepared at a vancomycin concentration of 2 g/48 mL in dextrose 5% and in sodium chloride 0.9% packaged in polypropylene syringes (Terumo) was physically and chemically stable for up to 48 hours at an ambient temperature ranging from 18 to 25°C.3602
No visual or subvisual changes were noted in polypropylene syringes containing vancomycin hydrochloride prepared at vancomycin concentrations of 40, 50, 58.8, 71, and 83.3 mg/mL in sodium chloride 0.9% in 24 hours at room temperature and 83.3 mg/mL in both sodium chloride 0.9% and dextrose 5% in 48 hours at room temperature.3603
Vancomycin hydrochloride (Sandoz) prepared at a vancomycin concentration of 3 g/48 mL in dextrose 5% and packaged in 50-mL polypropylene Plastipak (Becton Dickinson) syringes exhibited little loss in 24 hours at 20 to 25°C with no degradation products, change in pH, or visible modifications noted.3603 Syringes prepared at a vancomycin concentration of 4 g/48 mL in dextrose 5% exhibited a slight yellow color change and little loss in 6 hours at 20 to 25°C.3603 While the concentration of vancomycin in one of the 3 syringes (tested in triplicate) dropped below 90% of the initial concentration at 24 hours, the concentration in that syringe measured well above 90% of the initial concentration at 48 hours.3603 Authors attributed these results to a technical problem likely related to the multiple dilutions required to achieve the desired theoretical concentration of the drug and concluded that the drug was physically and chemically stable for 48 hours at 20 to 25°C.3603
Vancomycin hydrochloride (Sandoz) prepared at a vancomycin concentration of 3 g/48 mL in sodium chloride 0.9% and packaged in 50-mL polypropylene Plastipak (Becton Dickinson) syringes exhibited little loss in 48 hours at 20 to 25°C without any physical changes noted.3603 Syringes prepared at a vancomycin concentration of 4 g/48 mL in sodium chloride 0.9% exhibited little loss in 24 hours at 20 to 25°C, but a precipitate was observed after 48 hours of storage.3603
Vancomycin hydrochloride (Sandoz) reconstituted with either sterile water for injection or sodium chloride 0.9% and diluted in sodium chloride 0.9% was studied in polypropylene syringes (Becton Dickinson).4006 Syringes were prepared as vancomycin 0.5 g/20 mL (25 mg/mL) in 20-mL syringes and 2 g/50 mL (40 mg/mL), 3 g/50 mL (60 mg/mL), and 4 g/50 mL (80 mg/mL) in 50-mL syringes and stored at 25°C for 24 hours.4006 Although the 25-, 40-, and 60-mg/mL solutions exhibited little loss in 24 hours, counts of subvisible particles 10 µm or larger exceeded the USP limits for particulate matter in injections immediately and 24 hours after preparation.4006 The number of subvisible particles increased with increasing vancomycin concentration.4006 Visible particles were observed in the 80-mg/mL syringes after 22 hours.4006 Filtration through a 0.2-µm inline filter reduced particle counts to below the USP limits for the 25- and 40-mg/mL solutions only.4006
Elastomeric Reservoir Pumps
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 10 mg/mL in both dextrose 5% and sodium chloride 0.9% was evaluated for binding potential to natural rubber elastomeric reservoirs (Baxter). No binding was found after storage for 2 weeks at 35°C with gentle agitation.2014
Implantable Pumps
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 1 mg/mL in water in an implantable pump (Infusaid model 100) was incubated in a water bath at 37°C for 28 days. Vancomycin losses were substantial, with about 25% loss in 7 days and 40% loss in 28 days. At the end of the test period, a colloidal precipitate also was found in the pumps.1302
Sorption
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 15 mg/mL in dextrose 5% is reported to undergo substantial sorption to Teflon tubing used in an automatic dilutor (Syva). The vancomycin hydrochloride was apparently released from the tubing into subsequent solutions resulting in vancomycin toxicity.2153
Vancomycin hydrochloride prepared at a vancomycin concentration of 10 mg/mL with heparin sodium 5000 units/mL as an antibiotic lock in polyurethane central hemodialysis catheters lost about 50% of the antibiotic over 72 hours at 37°C. The loss was attributed to sorption to the catheters, although precipitation is also possible. Nevertheless, the reduced antibiotic concentration (about 5 mg/mL) remained effective against common microorganisms in catheter-related bacteremia in hemodialysis patients.2515; 2516
Plasticizer Leaching
Vancomycin hydrochloride (Qualimed Laboratories) prepared at a vancomycin concentration of 8 mg/mL in dextrose 5% and sodium chloride 0.9% in polyvinyl chloride (PVC) containers (Macropharma) did not leach detectable amounts of diethylhexyl phthalate (DEHP) plasticizer during simulated administration over 24 hours. If any DEHP was present, the concentration was less than 1 mcg/mL, the limit of detection in this study.2148
Filtration
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 2 mg/mL in dextrose 5% or sodium chloride 0.9% was filtered through a 0.22-µm cellulose ester filter (Ivex-HP, Millipore) over 6 hours. No significant drug loss due to binding to the filter was noted.1034
Central Venous Catheter
Vancomycin hydrochloride (Fujisawa) prepared at a vancomycin concentration of 2 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Infusion Solutions
In a simulated Y-site administration study, vancomycin hydrochloride (Fresenius Kabi) at a vancomycin concentration of 5 mg/mL in sodium chloride 0.9% was physically compatible with Normosol R for up to 4 hours at 21°C protected from light.3719
Peritoneal Dialysis Solutions
Reports have revealed that administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis, ranging from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever.3464; 3465; 3466; 3467; 3468; 3469 Manufacturers state that the safety and efficacy of vancomycin administered by the intraperitoneal route have not been established by adequate and well-controlled trials.3464; 3465; 3466; 3467; 3468; 3469
The activity of vancomycin 15 mg/L was evaluated in peritoneal dialysis fluids containing dextrose 1.5 or 4.25% (Dianeal 137, Travenol). Storage at 25°C resulted in virtually no loss of antimicrobial activity in 24 hours.515
Vancomycin hydrochloride (Lilly) prepared at vancomycin concentrations of 10 and 50 mg/L in peritoneal dialysis concentrate with dextrose 50% (McGaw) retained 93 to 100% of its initial activity after 24 hours of storage at room temperature.1044
The stability of vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 20 mg/L in peritoneal dialysis solutions (Dianeal 137 and PD-2) with heparin sodium 500 units/L was evaluated. Approximately 95 ± 12% activity remained after 24 hours at 25°C.1228
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 15 mg/L to 5.3 g/L in Dianeal with dextrose 2.5 or 4.25% was physically compatible with heparin sodium (Organon) 500 to 14,300 units/L for 24 hours at 25°C under fluorescent light. However, a white precipitate formed immediately in combinations of heparin sodium with vancomycin hydrochloride 6.9 to 14.3 g/L.1322
The retention of antimicrobial activity of vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 1 g/L alone and with each of two aminoglycosides, gentamicin sulfate (SoloPak) prepared at a gentamicin concentration of 120 mg/L and tobramycin sulfate (Lilly) prepared at a tobramycin concentration of 120 mg/L, in Dianeal PD-2 (Travenol) with dextrose 1.5% was evaluated. Little or no loss of any antibiotic occurred in 8 hours at 37°C. Vancomycin hydrochloride alone retained activity for at least 48 hours at 4 and 25°C. In combination with gentamicin sulfate and tobramycin sulfate, antimicrobial activity of both vancomycin and the aminoglycosides was retained for up to 48 hours. However, refrigeration at 4°C was recommended for storage periods greater than 24 hours.1414
The stability of vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 25 mg/L in Dianeal 137 (Baxter) with dextrose 1.36 and 3.86%, while protected from direct sunlight, was evaluated. At both dextrose concentrations, less than 4% vancomycin was lost in 42 days at 4°C. At 20°C, a 5% or less loss occurred in 28 days. At 37°C, a 10% loss occurred in 6 to 7 days.1654
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 1 mg/mL admixed with ceftazidime (Lilly) 0.5 mg/mL in Dianeal PD-2 (Baxter) with 1.5% and also 4.25% dextrose was evaluated for compatibility and stability. Samples were stored under fluorescent light at 4 and 24°C for 24 hours and at 37°C for 12 hours. No precipitation or other change was observed by visual inspection in any sample. No loss of either drug was found in the samples stored at 4°C and no loss of vancomycin and about 4 to 5% ceftazidime loss were found in the samples stored at 24°C in 24 hours. Vancomycin losses of 3% or less and ceftazidime loss of about 6% were found in the samples stored at 37°C for 12 hours. No difference in stability was found between samples at either dextrose concentration.2217
Vancomycin hydrochloride (Lederle) prepared at a vancomycin concentration of 0.05 mg/mL in Dianeal PD-2 with dextrose 1.5% with or without heparin sodium 1 unit/mL in PVC bags was chemically stable for up to 6 days at 4°C (about 3 to 5% loss) and 25°C (up to 7% loss) and 5 days at body temperature of 37°C.866
The addition of ceftazidime (Glaxo) 0.1 mg/mL to this peritoneal dialysis solution demonstrated a somewhat reduced stability with the ceftazidime being the defining component. The ceftazidime was chemically stable for up to 6 days at 4°C (about 3% loss), 3 days at 25°C (about 9 to 10% loss), and 12 hours at body temperature of 37°C with the vancomycin exhibiting less loss throughout.866
Vancomycin hydrochloride (Lederle) prepared at a vancomycin concentration of 25 mcg/mL in Delflex peritoneal dialysis solution bags with 2.5% dextrose (Fresenius) was stable with little loss occurring in 14 days refrigerated and at room temperature.2573
Gentamicin sulfate (American Pharmaceutical Partners) prepared at a gentamicin concentration of 8 mcg/mL with vancomycin hydrochloride (Lederle) prepared at a vancomycin concentration of 25 mcg/mL in Delflex peritoneal dialysis solution bags with 2.5% dextrose (Fresenius) was stable with little or no loss of either drug occurring in 14 days refrigerated and at room temperature.2573
Vancomycin hydrochloride (Abbott) prepared at a vancomycin concentration of 1 mg/mL in icodextrin 7.5% PD (Baxter) was tested for stability at 5, 24, and 37°C. The solutions remained clear and colorless. Little or no loss at 5°C and about 3% loss at 24°C after 7 days of storage was found. At 37°C, about 6% loss occurred in 24 hours.2650
Vancomycin hydrochloride (Hospira) prepared at a vancomycin concentration of 1 g/L in Extraneal with icodextrin 7.5% (Baxter) peritoneal dialysis solution bags exhibited less than 10% loss in 14 days at 25 and 4°C and 2 days at 37°C.3537 Vancomycin hydrochloride (Hospira) prepared at a vancomycin concentration of 1 g/L with gentamicin sulfate (Pfizer) prepared at a gentamicin concentration of 20 mg/L in Extraneal with icodextrin 7.5% (Baxter) peritoneal dialysis solution bags exhibited less than 10% loss of either drug in 14 days at 25 and 4°C and 7% loss of vancomycin and 3% loss of gentamicin in 4 days at 37°C.3537
Heparin Locks
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 25 mcg/mL and heparin sodium (Elkins-Sinn) 100 units/mL in sodium chloride 0.9% as a catheter flush solution were evaluated for stability when stored at 4°C for 14 days. The flush solution was visually clear, and the vancomycin activity and heparin activity were retained throughout the storage period. However, an additional 24 hours at 37°C to simulate use conditions resulted in losses of both agents ranging from 20 to 37%.1933
Vancomycin hydrochloride (Lilly) prepared at a vancomycin concentration of 25 mcg/mL and preservative-free heparin sodium (Elkins-Sinn) 100 units/mL in sodium chloride 0.9% in 2-mL glass vials for use as a central catheter flush solution were evaluated for compatibility and stability at 4 and 28°C. Visual inspection found no evidence of color change or particulate formation throughout the study. Heparin activity remained unchanged for 100 days. Acceptable vancomycin levels were maintained for 30 days at 28°C and for 63 days at 4°C. However, unacceptable losses occurred after those times. The activity of both drugs was unaffected by the presence of the other when compared to the activity of single drug controls.2542
Vancomycin hydrochloride prepared at a vancomycin concentration of 25 mcg/mL combined with heparin sodium (Hospira) 10 units/mL in sterile water for injection for use as a lock solution was found to be physically compatible. Little or no vancomycin loss occurred in 3 days at 4°C. However, losses of 8% occurred in 3 days at 27°C and 1 day at 40°C.2820 When ciprofloxacin (Sicor) 2 mg/mL was added to this flush solution, a white precipitate appeared within 1 day. Losses of both ciprofloxacin and vancomycin occurred as well.2820
Sodium Citrate Locks
The physical compatibility of catheter lock solutions prepared with sodium citrate 4% anticoagulant solution (Baxter) and vancomycin (manufacturer unspecified) 5, 10, and 20 mg/mL was evaluated.3482 Solutions were stored 22 to 23°C and at 37°C in a water bath, both exposed to light and in the dark.3482 No evidence of physical incompatibility was observed throughout the 48-hour study period in admixtures of sodium citrate with vancomycin concentrations of 5 and 10 mg/mL.3482 However, admixtures containing sodium citrate and vancomycin 20 mg/mL demonstrated spectrophotometric evidence of incompatibility in each of the 4 storage conditions, with demonstrated turbidity as assessed by absorbance.3482
The physical compatibility, chemical stability, and antimicrobial activity of catheter lock solutions prepared with sodium citrate 4% anticoagulant solution (Fenwal) combined with vancomycin (manufacturer unspecified) 5 and 10 mg/mL and either gentamicin (Hospira) 1 mg/mL or ethanol 40% (v/v) were evaluated.3473; 3483 Solutions were stored at 25 and 37°C, both with and without light.3473 All solutions remained visually clear and demonstrated mean pH changes of 0.1 or less from baseline at 72 hours, with the exception of the admixture containing sodium citrate 4% with vancomycin 5 mg/mL and ethanol 40%, which developed slight turbidity after 48 hours in all 4 storage conditions.3473 Spectrophotometric evaluation demonstrated mean gentamicin and vancomycin concentrations in the range of 95 to 105% of initial concentrations at 72 hours; similarly, antimicrobial activity of gentamicin and vancomycin at 72 hours was calculated to range between 95 and 106% of baseline based on disk diffusion methodology.3473
For a list of references cited in the text of this monograph, search the monograph titled References.